A Medical Device Daily
An Oct. 21 warning letter to Power Medical Interventions (PMI; Langhorne, Pennsylvania) indicated some serious compliance problems for the maker of surgical instruments, but none so serious that corrections documented in a couple of post-inspection letters could not turn the tide. For each of the 10 citations noted, FDA states in the warning letter that the agency "will verify compliance at a future inspection."
The warning letter states that PMI's complaint-handling procedures lacked "a requirement for investigating events associated with the use of your devices in clinical surgical procedures when patient information is missing." The letter also states that the company's marketing department released a limited but unspecified number of Power Line Cutters and reloads without a "source document data table."
The agency alleges that complaint files for the Power Line Cutter units "revealed one or more 'short cuts,'" but that the company did not follow up to check on "the surgical status of patients on whom the defective units were used." FDA states that the company also failed to establish what sort of correction was called for and "whether the events were MDR [medical device report] reportable."
The warning letter stated in a separate citation that PMI deemed device problems not reportable as MDRs "if the surgeon was able to complete a surgical procedure by utilizing another device" or by "performing another form of intervention." As was the case with all the findings, the company's four letters led to the notation "we will verify compliance at a future date."
The warning letter stated that PMI had conducted "no successful design validation studies" for a device that was redacted from the warning letter, but no further clarification is offered. At press time, the company had not responded to calls for comment.
Dems ask if FDA reviews 'corrupted'
As the saying goes, never ask how things could get worse, because you might not care for the answer. Just ask FDA. According to a Nov. 17 statement published by Rep. John Dingell (D-Michigan) – the beleaguered chairman of the House Energy and Commerce (E&C) Committee who is under pressure to yield his seat to Henry Waxman (D-California) – the Michigan Democrat intends to investigate allegations that FDA's Center for Devices and Radiological Health "knowingly corrupted the scientific review process and approved or cleared medical device applications in gross violation of laws and regulations designed to assure the safety and effectiveness of medical devices."
The statement indicates that Dingell and Bart Stupak (D-Michigan), the chairman of the E&C's oversight and investigations subcommittee, are looking into the situation based on "receipt of an October 14, 2008, letter written on behalf of a large group of CDRH scientists and physicians who state that CDRH managers have 'corrupted and interfered with the scientific review of medical devices.'"
Dingell's statement says that the allegations "are deeply concerning, and we intend to uncover whether any FDA activity has compromised the health and safety of America consumers."
In an accompanying letter addressed to FDA Commissioner Andrew von Eschenbach, MD, Dingell and Stupak write that they are "deeply disturbed by documents we received . . . from a large group of scientists and physicians working in the Center for Devices and Radiological Health who report misconduct within CDRH that represents an 'unwarranted risk to public health and a silent danger that may only be recognized after many years.'" The letter states that the FDA staffers could document that senior FDA personnel "ordered, intimidated and coerced FDA experts to modify their scientific reviews, conclusions and recommendations in violation of the law."
The letter to von Eschenbach also states that FDA had already decided "to task Mr. William McConagha, the assistant commissioner for integrity and accountability, to investigate these allegations in response to a letter you received from many of these same CDRH scientists on May 31, 2008," but complains that "no action has been taken to address the serious concerns raised by CDRH scientists or the retaliatory behavior of CDRH managers toward those concerned FDA employees."
Physician group fined $1 million
It's not just the Office of Inspector General (OIG) at the Department of Health and Human Services that's hounding providers to ensure that all their financial arrangements are on the up-and-up. According to a statement posted at the OIG web site, the Office of the U.S. Attorney for the Western District of Missouri has inked a settlement agreement with Ferrell-Duncan Clinic (Springfield, Missouri) that includes a fine of $1 million for prohibited financial arrangements with Cox Medical Centers (also Springfield).
According to the Oct. 30 statement, Ferrell-Duncan, "a medical practice comprised of approximately 100 physicians," violated both Stark laws and anti-kickback laws in the arrangement, but the statement gives no details as to the exact nature of the relationship.